Kornimate/medical-research-clean huggingface dataset:
evaluation of gait impairment and correlation with clinical assessment tools before and after surgery in patients with cervical myelopathy using inertial sensors

Conditions: Myelopathy Cervical

Summary: this study aims to evaluate gait impairment in patients with degenerative cervical myelopathy (dcm) before and after surgery using an inertial measurement unit (imu) sensor. by comparing imu-derived gait parameters with traditional clinical assessment tools (e.g., modified ashworth scale, mjoa, and grassp), the study seeks to determine the effectiveness and reliability of imu sensors for assessing and monitoring gait improvement and neurological recovery in dcm patients. this study is conducted outside the united states and does not involve interventions or devices subject to u.s. fda regulation.

this observational study will investigate the correlation between gait parameters measured with an imu sensor and established clinical evaluation tools for patients with degenerative cervical myelopathy (dcm). the primary aim is to quantify gait impairments before and after surgical intervention and to verify the imu sensor's utility as a quantitative assessment tool. the study will recruit both dcm patients and a control group to evaluate the sensitivity of the imu sensor in detecting fine motor and gait differences. outcomes will be analyzed using statistical comparisons of pre- and post-surgery measurements, with specific focus on gait speed, cadence, stride length, and spasticity. the anticipated goal is to validate the imu sensor as a reliable alternative to existing clinical tools, facilitating early detection of gait impairment and monitoring post-surgical improvement in dcm patients. this study is conducted entirely outside the united states and does not involve interventions or devices subject to u.s. fda regulation. the devices and procedures used in this study are approved by local regulatory authorities in the country where the study is conducted. the study complies with applicable international and local guidelines rather than u.s. fda requirements.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * able to communicate and provide informed consent. * capable of walking at least 3 meters without assistance from others or walking aids. * no prior surgical treatment for cervical myelopathy. * lower limb motor function score of 2 or higher on the mjoa scale. exclusion criteria: * presence of severe respiratory or cardiac conditions that impede safe walking. * musculoskeletal issues, such as spinal deformities, affecting gait. * history of neurological disorders affecting gait, including peripheral nerve injury, joint stiffness, stroke, traumatic brain injury, myelitis, or parkinson's disease. * prior orthopedic or neurosurgical interventions that could impact gait. * cervical conditions resulting from trauma (acute fracture or acute disc herniation), tumor, or infection.
randomized, controlled, multicenter study of extracellular vesicles from human adipose tissue promoting wound healing

Conditions: Wound Heal

Summary: by randomly assigning study subjects into groups, interventions with adipose tissue-derived extracellular vesicles (at-evs) and placebos are conducted to evaluate whether at-evs can promote effective healing of recalcitrant wounds.


Eligibility criteria:
inclusion criteria: * 1. age 18 to 69 years old, regardless of gender 2. full-layer skin ulcers on various parts of the body, lasting from 4 weeks to 1 year 1. if the wound is post-amputation, the time from surgery must be \>30 days; 2. if there is \>1 wound surface, the maximum wound surface is selected as the research target; 3. at the beginning of the induction period, the wound size after debridement was ≥1 and ≤20 cm2; 4.texas classification 1a, 1b, 1c, 1d, 2a, 2b, 2c or 2d; 5. ankle-brachial index ≥0.7, including percutaneous oxygen pressure (tcpo2) ≥30 mm hg and cutaneous perfusion pressure ≥30 mm hg; 6. revascularization procedures or vascular surgery that are not scheduled in the past or the next 30 days; 7. the subject and family members are willing and able to comply with all prescribed care and medical requirements; 8. the subject has a reasonable expectation of completing the study; 9. the subject completed the 2-week induction period and the wound was reduced by 30% exclusion criteria: * 1. the subject has signs of gangrene in any part of the trunk and limbs; 2. a written diagnosis of osteomyelitis in any part of the affected limb; 3. bone tissue at the wound site of the subject is exposed; 4. poor blood glucose control in subjects: hba1c\>12% (108 mmol/mol); 5. subjects are receiving renal dialysis treatment or creatinine \>2.5mg/dl (221mmol/l); 6. the subject has obvious immune deficiency; 7. the subject has suspected tumor or is receiving tumor treatment; 8. subject has used steroids or immunosuppressants in the past 3 months or is expected to use them during the study; 9. subjects received growth factor therapy, autologous platelet-rich plasma gel, double-layer cell therapy, dermal substitute, extracellular matrix, etc., during the screening period; 10. the subject has participated in another research device, drug, or biological trial within the past 30 days; 11. the wound shows serious clinical symptoms of infection, requiring hospitalization or immediate surgical treatment; 12. the subject has developed deep vein thrombosis within the past 30 days; 13. the subject is pregnant or breastfeeding; 14. the subject has serious mental illness and psychological disorder; 15. the subject was judged unfit for the test by the attending physician.
combination therapy with biofeedback, loperamide and stool bulking agents

Conditions: Fecal Incontinence

Summary: background: biofeedback and medical treatments have been extensively used for moderate fecal incontinence. there is limited data comparing and combining these two treatments. aim: to evaluate the effect of biofeedback and medical treatments, separately and in combination. methods: sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. the patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. a two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * patients with at least one or more episodes of fi during a period of 2 weeks as recorded by bowel function diary * patients from whom written consent was obtained exclusion criteria: * previous congenital or acquired spinal injury, spinal tumour or spinal surgery * presence of neurological diseases or peripheral vascular disease * uncontrolled diabetes mellitus * congenital anorectal malformations * recent colorectal or gastrointestinal surgery * presence of external full-thickness rectal prolapse * inflammatory bowel disease * chronic diarrhoea * use of tibial nerve or sacral nerve stimulations * ongoing pregnancy * any malignant disease
walnuts to achieve lasting nutrition to prevent diabetes

Conditions: PreDiabetes; Overweight and Obesity

Summary: prediabetes is a precursor of type 2 diabetes and an independent risk factor for cardiovascular disease, and currently affects one-quarter of the population of the united states. individuals of overweight or obese bmi are at particular high risk for incident diabetes. a major modifiable risk factor for type 2 diabetes is poor dietary quality, and improvement of dietary quality can effectively delay and even prevent type 2 diabetes. interventions to improve dietary quality thus far, however, rely on short-term intensive clinically designed meals replacing the entire diet which have poor sustainability. persistent improvements to daily dietary patterns are often difficult without directed guidance, and overall dietary quality in the united states remains poor. the identification of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in those at high risk remains unknown. the investigators propose to enroll 40 individuals with diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut supplementation intervention to determine feasibility and acceptability of the supplement. the investigators will then determine preliminary efficacy on metabolic markers and will investigate associations between dietary quality and circulating levels of branched-chain amino acids. the goal is to implement a whole-food supplement to improve dietary quality in patients with prediabetes as a tool for future type 2 diabetes prevention.


Eligibility criteria:
inclusion criteria: 1. male or female between 18-65 years of age at baseline living in the san francisco bay area. 2. bmi\>25 m/kg2 (or \>23 m/kg2 for individuals of asian or south asian ethnicity) 3. documentation of prediabetes diagnosis as evidenced by the following criteria: 1. a fasting glucose 100-125 mg/dl, or a hba1c measurement of 5.7-6.4%, or a diagnosis of "prediabetes" or "impaired fasting glucose" in the past 6 months, identified through an electronic medical record query from patients at ucsf and through outside recruitment in the surrounding community 2. we will confirm eligibility of potential participants by repeating fasting capillary blood glucose measurements at the baseline visit to ensure that they have prediabetes 4. written informed consent and ability for subject to comply with the requirements of the study. exclusion criteria: 1. pregnant or breastfeeding women at enrollment. 2. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data, such as diverticulosis or diverticulitis. 3. tree or peanut allergies 4. unwilling to consume a daily walnut supplement. 5. diagnosis of diabetes 6. on glucose lowering medications 7. dietician-managed dietary intake, or personal or medical dietary restrictions that do not allow consumption of walnuts 8. malabsorptive conditions including intestinal bypass surgery, pancreatitis, inflammatory bowel disease
migration and survival of all-polyethylene tibial all poly components compared to the metal-backed modular components of the triathlon cs total knee system. a single center rsa study

Conditions: Arthritis

Summary: the primary objective is the assessment of prosthetic migration results after two years of the triathlon cs knee system with all-polyethylene tibial components compared to the triathlon cs knee system with metal-backed modular components by means of roentgen stereophotogrammetry.

the secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. in order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the rsa outcome. the 10 years results will be used to verify the predicted long-term survival results.

Eligibility criteria:
1. the subject is morbidly obese, defined as body mass index (bmi) of \> 40. 2. patient has a flexion contracture of 15° and more. 3. patient has a varus/valgus contracture of 15° and more. 4. patients with a pre-operative knee score of \>70. 5. the subject has a history of total or unicompartmental reconstruction of the affected joint. 6. the subject will be operated bilaterally. 7. patients who had a total hip arthroplasty (tha) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (patients with contralateral and/or ipsilateral tha \> 1 year ago with good outcome can be included in the study). 8. patients who had a total knee arthroplasty (tka) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (patients with contralateral tka \> 6 months ago with good outcome can be included in the study). 9. the subject has an active or suspected latent infection in or about the knee joint. 10. osteomyelitis 11. sepsis 12. patient who is expected to need lower limb joint replacement for another joint within one year. 13. the subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. the subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. the subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. the subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. the subject has had a knee fusion to the affected joint. 18. female patients planning a pregnancy during the course of the study. 19. the patient is unable or unwilling to sign the informed consent specific to this study
individualized duration of peg-interferon/ribavirin treatment of hepatitis c

Conditions: Chronic Hepatitis C, Genotype 1

Summary: the purpose of the study is to investigate if the duration of treatment of hepatitis c with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis c virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.

the current standard regimen for patients with chronic hepatitis c virus (hcv) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of hcv. according to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when hcv-rna becomes undetectable (week 4, 12 or 24). patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation. in this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when hcv rna level is calculated to be 1 copy/ml, according measurements of hcv rna on day 14, 21, 28 and 49. this arm also includes an earlier stopping rule: if the hcv rna does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks. the advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.

Eligibility criteria:
inclusion criteria: * anti-hcv positive for \> 6 months * genotype 1 * clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis * negative pregnancy test (for fertile women) exclusion criteria: * pregnancy or breast-feeding * antiviral or immune modulating treatment the last 6 months * hepatitis b or hiv infection (hbsag, anti-hiv) * other significant chronic liver disease * history of bleeding esophageal varices or other signs of decompensation * neutrophiles \ 2 x uln * history of severe psychiatric disorder * autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy * drug abuse, current or during the last year

Keywords: hepatitis c virus real-time pcr treatment
a study of chemoradiation plus pembrolizumab for locally advanced laryngeal squamous cell carcinoma

Conditions: Head and Neck Cancer

Summary: the purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for larynx cancer. the standard of care treatment will include chemotherapy and radiation for 7 weeks.

this study is an open label, single arm study which will enroll patients with locally advanced squamous cell carcinomas of the larynx. positive tumor pdl1 expression by ihc will not be required for enrollment. all patients with receive pembrolizumab and cisplatin in combination with radiation. pembrolizumab 200 mg flat dose given q21 days will begin 3 weeks prior to initiation of chemoradiation and continued through the 21-day cycle until completion of chemoradiation. cisplatin will be given 100 mg/m2 every 21 days during radiation as per standard of care. pembrolizumab has well defined toxicities as single agent and has non-overlapping mechanisms of action with cisplatin and radiation. the safety of these agents used in combination has not been previously described, therefore the study will begin with a safety run-in phase 1 followed by the phase ii design. see statistical section for details.

Eligibility criteria:
inclusion criteria: * biopsy-proven, previously untreated stage iii or iv squamous cell carcinoma of the larynx, primary tumor stage (t2, t3) and nodal stage (n0, n1, n2, n3). * measurable disease based on recist 1.1. * performance status 0 or 1 on eastern cooperative oncology group performance scale. * anticipated survival minimum of 12 months. * adequate labs exclusion criteria: * patients with t1 primary tumor or t4 large volume tumor that has resulted in larynx dysfunction at baseline (for example tumor largely penetrating into base of tongue and resulting in inability to swallow at baseline) * prior radiation therapy to the larynx area or involved neck. * distant metastasis * known history of active tuberculosis (tb), autoimmune disease, pneumonitis, infection, hiv, hepatitis b, or hepatitis c
a study of the safety and pharmacokinetics of mfgr1877s in patients with relapsed or refractory t(4;14)-positive multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a multicenter, open-label, dose-escalation study of mfgr1877s in patients with relapsed or refractory t(4;14)-positive multiple myeloma.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0, 1, or 2 * life expectancy of at least 12 weeks * histologic documentation of previously treated t(4;14)-positive multiple myeloma for which no effective standard therapy exists exclusion criteria: * prior use of any monoclonal antibody before study treatment * treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks of study treatment * completion of autologous stem cell transplant within 6 months prior to study treatment * prior allogeneic stem cell transplant * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy * evidence of significant, uncontrolled concomitant diseases, including significant cardiovascular disease or pulmonary disease * known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening or any recent major episode of infection requiring treatment with iv antibiotics or hospitalization prior to study treatment * recent major surgery (prior to study treatment), other than for diagnosis * presence of positive test results for hepatitis b or hepatitis c * known history of hiv seropositive status * women who are pregnant or lactating * childbearing potential without agreement to use effective form of contraception for the duration of the study
safety and efficacy of the use of botox on acne

Conditions: Acne Vulgaris

Summary: • to determine the safety and efficacy of botox treatment in subjects with mild to moderate acne vulgaris defined by the investigator's global assessment (iga)

• 90 day trial, with botox being injected at baseline/screening visit. photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. patient will complete a subject evaluation at each visit. follow-up visits occur at day 3, 7, 14, 30 and 90.

Eligibility criteria:
inclusion criteria: * between the age of 18 and 50 years of age * not pregnant and negative pregnancy test, not planning on getting pregnant * mild to moderate bilateral acne lesions on the face * able to understand the requirements of the study and sign an informed consent form * have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study) * skin types i, ii, iii, iv and v exclusion criteria: * subject has skin type vi * subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease * concurrent skin conditions affecting area to be treated * prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment * prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation * open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi in areas to be treated? * permanent or semi-permanent dermal filler treatment within the last 6 months * medium or deep depth chemical peel resurfacing procedure within 3 months of treatment or during this clinical evaluation * has used oral isotretinoin (accutane) within 6 months, or use of topical isotretinoin within 3 months, of initial treatment or during this clinical evaluation * prior light /laser treatments at target locations within 3 months of enrollment or during the course of this clinical evaluation * any physical or mental condition which, in the investigator's opinion would make it unsafe for the subject to participate in the clinical evaluation * use of oral antibiotics for acne and/or medication that cause photosensitivity within 2 weeks of initial treatment * participation in a study of another investigational devices or drugs within 3 months of enrollment * subject shows symptoms of a hormonal disorder * subject cannot be treated for (past or present) any form of treatment of active cancer or having a history of skin cancer or any other cancer in the area to be treated * subject is currently using immunosuppressive medications

Keywords: acne botox cosmetic treatments
the effect of arginine and glutamine on covid-19 patients outcome: a randomized clinical trial

Conditions: COVID-19

Summary: the goal of this clinical trial is to determine effect of arginine and glutamine on outcome of covid-19 patients. the main questions it aims to answer are: -to test the effect of oral nutritional supplements containing arginine and glutamine on covid-19 patients outcome dr. m. djamil general hospital padang participants will given ons containing arginine and glutamine. researchers will compare intervention group with control group to see if ons affected outcome of covid-19 patients


Eligibility criteria:
inclusion criteria: * patients confirmed positive for covid-19 * age over 17 years * the patient can take food orally exclusion criteria: * patients with restricted fluid intake * patients who cannot take food orally * suffering from diabetes mellitus and kidney failure

Keywords: covid-19 oral nutrition supplement